# K151603: Arcos One-piece Femoral Revision System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 6, 2015 after 116 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921308 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090757: Biomet Modular Femoral Revision System, Biomet, Inc. (2009) Summary page 5.
- K000760: Reach Femoral Component, Biomet, Inc. (2000) Summary page 5.

## Indications for use
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision procedures where other treatment or devices have failed. The Arcos One-Piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.

Source page: https://510kreport.com/device/K151603
Methodology: https://510kreport.com/methodology